FDA.reportPublic FDA data

Clonidine Hydrochloride

Product NDC
0228-2129
11-digit product format
002282129
Labeler code
0228
Product ID
0228-2129_860129c9-0bba-471e-a90c-b6bede1833b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clonidine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA070976
Marketing category
ANDA
Marketing start
1995-01-03
Substance
CLONIDINE HYDROCHLORIDE
Active strength
.3 mg/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clonidine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLONIDINE HYDROCHLORIDE.3 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW76I6XXF06
Rxcui884173, 884185, 884189

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
45c8ba14-e378-46f0-b21f-1aad8e08c613Product name120250221
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name920190618
6920b0ed-30bc-b127-73e1-0713049bd41eProduct name520171212
48f5a4fd-7cdc-dc04-771d-ce7a47326789Product name220150123
624cf764-e200-44b5-83c2-84526255adb5Product name120150107
47972e1b-c905-eeee-5e77-eb4538ad833cProduct name120140508
7667d8e2-e5be-36e1-4de7-231aa7fdaf5cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0228-2129-10Clonidine Hydrochloride100 in 1 BOTTLETABLET10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-2129-10EA - Each0228-21290bc78a62-4ff9-4873-ad4f-15b91476c88112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLONIDINE HYDROCHLORIDEACTIVE INGREDIENTW76I6XXF06CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
CLONIDINEACTIVE MOIETYMN3L5RMN02CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLONIDINE HYDROCHLORIDE TABLET [ACTAVIS ELIZABETH LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-2129CLONIDINE HYDROCHLORIDE TABLET [ACTAVIS PHARMA, INC.]17Current NDC, Legacy NDC, 1 package rows20231216_a842ab83-3531-44dd-a8a8-64dd89e87026.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884173cloNIDine HCl 0.1 MG Oral TabletPSNa842ab83-3531-44dd-a8a8-64dd89e8702618
884185cloNIDine HCl 0.2 MG Oral TabletPSNa842ab83-3531-44dd-a8a8-64dd89e8702618
884189cloNIDine HCl 0.3 MG Oral TabletPSNa842ab83-3531-44dd-a8a8-64dd89e8702618
884173clonidine hydrochloride 0.1 MG Oral TabletSCDa842ab83-3531-44dd-a8a8-64dd89e8702618
884185clonidine hydrochloride 0.2 MG Oral TabletSCDa842ab83-3531-44dd-a8a8-64dd89e8702618
884189clonidine hydrochloride 0.3 MG Oral TabletSCDa842ab83-3531-44dd-a8a8-64dd89e8702618
884173clonidine HCl 100 MCG Oral TabletSYa842ab83-3531-44dd-a8a8-64dd89e8702618
884185clonidine HCl 200 MCG Oral TabletSYa842ab83-3531-44dd-a8a8-64dd89e8702618
884189clonidine HCl 300 MCG Oral TabletSYa842ab83-3531-44dd-a8a8-64dd89e8702618
884189cloNIDine HCl 0.3 MG Oral TabletPSNacdddd91-ffe3-4b9b-9c59-0328e018b6627
884189clonidine hydrochloride 0.3 MG Oral TabletSCDacdddd91-ffe3-4b9b-9c59-0328e018b6627
884189clonidine HCl 300 MCG Oral TabletSYacdddd91-ffe3-4b9b-9c59-0328e018b6627
884189cloNIDine HCl 0.3 MG Oral TabletPSNe9b22c56-a3fc-46df-b745-11c4ac309a911
884189clonidine hydrochloride 0.3 MG Oral TabletSCDe9b22c56-a3fc-46df-b745-11c4ac309a911
884189clonidine HCl 300 MCG Oral TabletSYe9b22c56-a3fc-46df-b745-11c4ac309a911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0228-2129-1000228212910100 TABLET in 1 BOTTLE (0228-2129-10) 100 tablet1995-01-030000-00-00NoNoCurrent